Clinical Trials Logo

Clinical Trial Summary

Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis


Clinical Trial Description

The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04926818
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 3
Start date October 5, 2021
Completion date June 1, 2029

See also
  Status Clinical Trial Phase
Recruiting NCT05177523 - Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis
Not yet recruiting NCT03624296 - Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study N/A
Terminated NCT04203498 - Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis Phase 3
Active, not recruiting NCT04602390 - Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis Phase 1
Completed NCT01804647 - Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
Recruiting NCT04907305 - Next-Gen MS: Feed-forward PRO Data for MS Research
Active, not recruiting NCT03456206 - Chronic Inflammatory Disease, Lifestyle and Risk of Disease
Completed NCT04705610 - Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography N/A
Completed NCT01366027 - PRISM Registry: Pseudobulbar Affect Registry Series N/A
Not yet recruiting NCT06053749 - An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden
Completed NCT03135249 - Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis Phase 4
Recruiting NCT05633875 - Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis
Completed NCT02612935 - An Observational Pilot Study of Lumosity Computerized Cognitive Training in Subjects With Multiple Sclerosis N/A
Completed NCT02739542 - Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) Phase 4
Completed NCT03177655 - Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis N/A
Active, not recruiting NCT04777539 - Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Recruiting NCT02352194 - Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis N/A
Completed NCT02308579 - Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases N/A
Completed NCT02019927 - Electric Stimulation of the Eye to Improve Vision After Trauma N/A
Withdrawn NCT01710228 - Alternative Treatment Paradigm for Natalizumab Trial Phase 2